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RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well 17-N-allylamino-17-demethoxygeldanamycin works in treating patients with metastatic malignant melanoma.

Condition or disease

Intervention/treatment

Phase

Melanoma (Skin)

Drug: tanespimycin

Phase 2

Detailed Description:

OBJECTIVES:

Primary

Determine the antitumor activity of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with metastatic malignant melanoma.

Determine the progression-free rate in patients treated with this drug.

Secondary

Determine the toxicity profile of this drug in these patients.

Determine the duration of response in patients treated with this drug.

Determine the survival of patients treated with this drug.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses of treatment, disease response is assessed. Patients with stable or responding disease receive additional courses of treatment.

After completion of study treatment, patients are followed at 28 days and then every 3 months thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 12-18 months.

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed malignant melanoma

Metastatic (M1a, M1b, or M1c) disease

Measurable disease by clinical exam, x-ray, CT scan, or MRI

Must have documented disease progression at 2 time points separated by ≥ 6 months

Pre-existing visceral lesions or the appearance of new visceral lesions allowed

New skin disease amenable to surgery not allowed

No primary brain tumors or brain metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

More than 3 months

Hematopoietic

WBC ≥ 3,000/mm^3

Platelet count ≥ 100,000/mm^3

Absolute neutrophil count ≥ 1,500/mm^3

Hemoglobin ≥ 9.0 g/dL

Hepatic

Bilirubin normal

ALT and AST ≤ 1.5 times upper limit of normal

No chronic liver disease

No known hepatitis B or C positivity

Renal

Creatinine < 130 mmol/L OR

Creatinine clearance > 60 mL/min

Cardiovascular

No symptomatic congestive heart failure

No myocardial infarction within the past 6 months

No unstable angina pectoris

No cardiac arrhythmia

No transient ischemic attack

No stroke or peripheral vascular disease

Other

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective contraception for 4 weeks before, during, and for 6 months after study participation

No ongoing or active infection

No diabetes mellitus with evidence of severe peripheral vascular disease or ulcers

No history of allergy to eggs

No known HIV positivity

No psychiatric illness or social situation that would preclude study compliance

No other uncontrolled illness

No other malignancy except adequately treated cone-biopsied carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

More than 4 weeks since prior immunotherapy

Chemotherapy

More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

More than 4 weeks since prior endocrine therapy

Concurrent steroids allowed provided they are given at the lowest possible maintenance dose

Radiotherapy

More than 4 weeks since prior radiotherapy unless administered for palliative care

Concurrent radiotherapy allowed provided it is administered as a single fraction for bone pain OR as indicated for palliative care